Clinical studies of prescription drugs for heart failure have often not reported the side effects of these drugs separately for men and women, describe Hester den Ruijter and Sophie Bots in the journal Circulation. A more comprehensive analysis of all available literature on medication for heart failure in JACC Heart failure, shows a similar pattern: the data are presented for men and women together while men and women with heart failure are obviously different.
For this review, 23 clinical trials and 155 observational studies were reviewed that contained relevant information for the study. Of the 23 clinical trials, only two (9%) reported side effects for men and women separately. Among the observational studies, 11 out of 155 (7%) did. Four of these studies reported more side effects in women, mainly for angiotensin converting enzyme (ACE) inhibitors and digoxin. One study of the mineralocorticoid receptor antagonist (MRA) spironolactone found more side effects in men. The remaining six studies found no male-female differences. These data suggest that men and women may respond differently to some heart failure drugs, but do not provide enough information to make a confident statement. “More global knowledge about gender-specific side effects of heart failure medications in academia is necessary and leads to better care because practitioners can better tailor their medication choices to the patient,” Den Ruijter and Bots conclude.
About 230 thousand people in the Netherlands live with heart failure, of whom slightly more than half are women (125 thousand). It is known that women generally have a risk of side effects one and a half times higher than men when taking the same cardiovascular medication. These side effects can be life-threatening, such as the occurrence of an arrhythmia. But side effects that do not seem threatening at first glance, such as persistent dry cough, can also cause a person to stop taking the medication. This can cause a person to miss out on the positive effects of the medication, and this can lead to long-term health deterioration. However, this has never been studied specifically for heart failure, which is relevant because heart failure manifests differently in men and women and this also has implications for treatment choice and the risk of side effects.
Den Ruijter and Bots recommend that any new study should report results for men and women separately. To achieve this, it is important to pay attention to this early in scientists’ careers. “Diversity is an important focus of education at UMC Utrecht,” says Gönül Dilaver, associate professor of innovative Bio/Medical Education. Dilaver is developing a course designed to train researchers of the future to become aware of diversity between people. The physiological differences between men and women, for example, have so far been very under-researched. This is partly a result of the way students are trained, and we want to change that in education.”
Dr. Hester den Ruijter is principal investigator of Experimental Cardiology at UMC Utrecht. She conducts scientific research on the differences in cardiovascular disease between men and women, with a special focus on the female heart. Sophie Bots is doing her PhD research on male-female differences in heart failure at the Experimental Cardiology research team at UMC Utrecht.
The research was co-funded by the Heart Foundation and ZonMW.
